Mainz Biomed NV Stock Price, News & Analysis

Mainz Biomed (NASDAQ:MYNZ) signed a Memorandum of Understanding with OncoVanguard8 to introduce ColoAlert, a DNA-based colorectal cancer screening test, to South America beginning with Peru. The MOU outlines core commercial, legal and regulatory terms and a go-to-market strategy for an initial territory, with a final distribution agreement targeted within weeks.

The companies identified Peru, Colombia and Ecuador as initial launch markets, where about 17,000 new colorectal cancer cases are diagnosed annually, highlighting demand for early-detection screening solutions that could raise participation and support public health goals.

Mainz Biomed (NASDAQ:MYNZ) will participate in MEDICA 2025 in Düsseldorf from November 17–20, 2025. MEDICA expects >5,000 exhibitors from 70 countries and about 80,000 visitors, offering a global platform for medical-technology networking, forums, and business development.

Mainz Biomed will showcase its flagship molecular stool-based colorectal cancer screening test ColoAlert and preview additional early-stage cancer diagnostic solutions. The company will be at the Rhineland-Pfalz joint booth in Hall 3, E92. Investors and attendees are directed to the company investor site for more information and social channels for updates.

Mainz Biomed (NASDAQ:MYNZ) announced it will attend the 38th Annual Meeting of the Gastroenterological Working Group of Rhineland-Palatinate (GARPS) from 14–15 November 2025 in Bad Kreuznach, Germany.

The company plans to present its flagship diagnostic ColoAlert® and discuss upcoming solutions for early detection of colorectal and other cancers, engage with gastroenterology key opinion leaders, and explore clinical collaborations. Attendees are invited to visit Mainz Biomed's booth to learn about offering ColoAlert to patients.

For more information, investors and physicians are directed to the company investor site at mainzbiomed.com/investors/ and the company's social channels.

Mainz Biomed (NASDAQ:MYNZ) will attend the 2025 Maxim Growth Summit in New York City on October 22-23, 2025 at The Hard Rock Hotel NYC. The company, which focuses on molecular genetics diagnostics for early cancer detection, said it will meet one-on-one with institutional investors and senior Maxim analysts during the event.

The summit features keynote speakers and roundtable sessions across sectors including biotechnology, AI, stem cell therapy and more. For the summit agenda visit www.maximgrp.com/2025-growth-summit and for investor information visit mainzbiomed.com/investors/.

Mainz Biomed (NASDAQ:MYNZ) reported topline feasibility results for a non-invasive, blood-based pancreatic cancer screening test using 18 licensed biomarkers. In a 30-subject cohort the leading panel achieved 100% sensitivity and 95% specificity, and the algorithm also detected precancerous lesions. These results align with earlier discovery/validation datasets that showed 95% sensitivity and 98% specificity. Mainz Biomed will plan a larger confirmatory study using banked retrospective samples, then a PCR-based validation study and potential future FDA submission, pending outcomes.

Mainz Biomed (NASDAQ:MYNZ) will present groundbreaking clinical data from their eAArly DETECT study at the World Endoscopy Organization's CRC Screening Committee Meeting on October 3rd, 2025 in Berlin.

Dr. Lena Krammes will showcase the company's RNA-based diagnostic test results, which demonstrated remarkable efficacy with 97% sensitivity and specificity for colorectal cancer detection, 82% sensitivity for advanced adenomas, and 100% detection rate for advanced adenomas with high-grade dysplasia.

The presentation, titled "From Detection to Prevention," will highlight the potential of stool RNA testing in both early cancer detection and prevention through identification of high-risk lesions.

Mainz Biomed (NASDAQ:MYNZ) has announced the commercial launch of its flagship product ColoAlert® in Switzerland, marking a significant expansion of its colorectal cancer screening solution. The launch follows three key achievements: a strategic partnership with labor team w ag, one of Switzerland's leading diagnostic laboratories; regulatory approval from Swissmedic; and successful completion of technology transfer to labor team's facility in Goldach.

Additionally, the company provided an update on its eAArly DETECT 2 Study, which aims to enroll 2,000 average-risk patients. Management has decided to proceed with complete enrollment through the end of 2025 without pausing for an interim readout.

Mainz Biomed (NASDAQ:MYNZ) has achieved a significant milestone with the registration of ColoAlert®, its DNA-based colorectal cancer screening test, by the UK's Medicines and Healthcare products Regulatory Agency (MHRA). This regulatory approval enables marketing authorization across the United Kingdom.

The registration follows Mainz's technology partnership with EDX Medical Group plc and aims to address the UK's colorectal cancer burden, where approximately 44,000 new cases are diagnosed annually. ColoAlert will complement the existing Bowel Cancer Screening Program, which currently serves people aged 50-74, by providing a non-invasive screening option that detects DNA biomarkers in stool samples.

Mainz Biomed (NASDAQ:MYNZ) has received regulatory approval from Swissmedic to market ColoAlert®, its non-invasive colorectal cancer screening test, in Switzerland. The approval follows the company's partnership with labor team w ag, a local Swiss laboratory.

The Swiss market represents a significant opportunity, with 2.8 million people (31.4% of the population) in the target age group of 50-74 years. Current colorectal cancer screening participation rates in Switzerland are below 50% despite having over 13 screening programs nationwide. ColoAlert®, designed to detect CRC tumor DNA and other biomarkers in stool samples, aims to improve these participation rates.